In performing a tracheostomy, it is generally necessary to perform a dissection for insertion of a breathing tube into the trachea. However, it is preferable to perform such tracheostomies utilizing devices which do not require surgical skill to perform the dissection. Apparatus has been developed to avoid the dissection procedures, including U.S. Pat. Nos. 3,511,243, 4,364,391 and 4,471,778. See also U.S. Pat. Nos. 4,699,611 and 5,009,643.
In the U.S. Pat. No. 4,978,334, a device is described which utilizes a single needle attached to a syringe having a dilator coaxially mounted therewith. Coaxially mounted around the dilator is a breathing tube. To perform a percutaneous tracheostomy with such a device, the needle is inserted into the lumen and the syringe plunger is withdrawn to confirm proper location of the needle. Upon confirmation of the needle location, the dilator is coaxially moved over the needle and into the lumen to serve as a flexible leader for the breathing tube. The coaxial arrangement of the dilator and breathing tube permits the removal of the dilator from the trachea leaving the breathing tube in place.
Notwithstanding the advantages of the apparatus disclosed in U.S. Pat. No. 4,978,334, it continues to be difficult to perform a percutaneous insertion of the needle and dilator so as to avoid passage of the device through the lumen into the walls and surrounding tissue thereof. Also, upon removal of the syringe and needle from the dilator, it is not abnormal to also pull the dilator out of position. Without the notch the dilator is relatively rigid and now likely to perforate the lumen wall, especially if the needle is not removed. Provision for a guide wire is not made with this invention. Accordingly, it is an object of the present invention to provide a device for percutaneous tracheostomy and/or cricothyroidectomy which overcomes prior art limitations. In particular, it is an object of this invention to provide a percutaneous device in which the dilator provides an indication of proper location in the lumen and resists accidental removal.